Opinions of the Expert Committee for Prions regarding Implementing a Risk Assessment on Beef and Beef Offal Imported to Japan

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1 Opinions of the Expert Committee for Prions regarding Implementing a Risk Assessment on Beef and Beef Offal Imported to Japan Background - The Food Safety Commission (FSC) implements risk assessments at its own initiative (self-tasks) as well as those in response to consultations by risk management agencies. - Subjects for self-tasks are nominated at the Expert Committee for Planning, in the light of high potential risk, major public concern and large social impact. - Japan also imports beef and beef offal from countries other than the United States and Canada, where no BSE infected cattle has been detected. Some of these countries were categorised as level III of the Geographical BSE Risk (GBR) by the European Food Safety Agency (EFSA), i.e. it was likely but not confirmed that domestic cattle were (clinically or pre-clinically) infected with the BSE-agent, while some of others have not been assessed by EFSA GBR. Japanese risk management agencies require importers of beef and beef offal to submit an official health certificate confirming the products are not originated from disease cattle, and to refrain from importing specified risk materials (SRM), and inspect them at the quarantine stations. However, potential risk of imported beef and beef offal is not sufficiently clarified partially because BSE prevalence and its countermeasures in those countries are unknown. - The risk assessment on beef and beef offal imported to Japan was requested at the public meetings and others. - These requests seem to be because people feel anxious that the risk of beef and beef offal imported from other countries than the U.S. / Canada is unknown owing to lack of risk assessments. History of Deliberations - November 2005: A risk assessment on beef and beef offal imported from Mexico, Chile and China was nominated as a subject for self-tasks at the Expert Committee for Planning.

2 - 15 th June 2006: This matter was reported to the 147 th FSC meeting and it was decided to hear opinions of the Expert Committee for Prions. - 22nd June 2006: In response to the above mentioned decision, we deliberated this matter at the 36 th meeting and reported the following opinion to FSC; the current BSE status in the subject countries must be investigated by collecting relevant information and it is required to discuss on the procedure of the assessment and necessary survey items, in advance of commencing the assessment th June 2006: FSC endorsed the above mentioned opinion and asked us to set about a preliminary discussion, at the 149 th FSC meeting. - We had seven meetings (from 37 th to 43 rd ) before finalised this report. Terms of Reference We were remitted to discuss the following matters by FSC. - To get hold of the current BSE contamination status in the countries other than the U.S. / Canada which export beef and beef offal to Japan by collecting information. To summarise discussion on how to proceed the risk assessment on beef and beef offal imported from these countries and necessary survey items for the assessment. Result of Deliberations at the Expert Committee for Prions The risk assessment will likely encounter difficulties such as lack or insufficiency of relevant data / information, and consequently might result in reporting unknown risk, even if commenced. It is however necessary to clarify the risk of imported beef and beef offal as much as possible since people are anxious that the risk is currently not always known. Therefore, it is appropriate to assess the risk of beef and beef offal imported to Japan as self-tasks, with public request taken into account. The procedure and survey items of the risk assessment are as follows, when the assessment will be implemented. 1 BSE status in the subject countries We attempted to get hold of the current BSE status in the subject countries based on information collected so far.

3 The collected information covers mostly the following areas. - Actual imports (the quantity of imported beef from thirteen countries) - GBR assessment by EFSA (including countries categorised as level III or un-assessed) - Countermeasures to BSE (e.g. feed ban, surveillance programme, appropriate procedure of slaughter) - Japanese risk management measures at the time of import (e.g. animal health condition) 2 How to proceed the risk assessment (An objective of the risk assessment) - It is necessary to clearly set an objective of the assessment when implementing self-tasks while an objective is shown by risk management agencies in case of their consultation. - The objective of this assessment lies in evaluating the risk of beef and beef offal imported from the subject countries when consumed as food. (Basic concepts) - Basically, it seems to be appropriate to comprehensively evaluate risk regarding the following items, based on the methodology when having assessed the risk of domestic, the U.S. / Canadian beef products, in accordance with scientific knowledge and considering change of risk over time. i) risk of live cattle (e.g. risk estimated from external and internal challenges, risk verified by surveillance programmes) ii) risk of beef and beef offal (e.g. risk of slaughtered cattle, risk through each procedure of slaughter and others) - Risk should be evaluated as much quantitatively as possible while it could end up with qualitative assessment due to insufficient data / information. It will be considered to use a reasonable worst-case scenario when available information will be limited. - Risk would be expressed by qualitatively negligible or undetermined, quantitatively absolute values, or qualitative/quantitative comparison.

4 (Method of working for the assessment) - Obtaining information: Information will be obtained through questionnaires and inquiries to the subject countries regarding survey items. It is essential to verify the credibility of the information submitted from the subject countries by means of asking them, cross-checking with other data / information and such. - Summarising a result of deliberation and assessment: We implement survey and deliberation based on scientific knowledge. Opinions of other experts than us should be asked when necessary. It should be considered to ask comments on draft results towards the subject countries when summarising the results, in addition to usual public comment. Misinterpretation of the obtained data can be avoided and the credibility of the results can be raised by these procedures. 3 Necessary survey items for the assessment - It is appropriate to examine the attached survey items when implementing risk assessment, based on items used in GBR and our assessment for beef and beef offal from the U.S. / Canada, with pay attention to survey items of the OIE code. 4 Other considerations - Proactive risk communication with stakeholders should be encouraged when implementing a risk assessment. (e.g. exchange of opinions with stakeholders when deciding to implement an assessment, cooperation with risk management agencies in collecting data and asking their opinions, public comments towards draft assessment results) - Member states of WTO should base their sanitary or phytosanitary measures on international standards, guidelines or recommendations (e.g. the OIE code) according to the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement). However, measures which result in a higher level of protection may be introduced or maintained if there is a scientific justification. The risk will be scientifically evaluated by considering these matters. - It is fundamental that necessary information should be intensively collected from the countries for which a risk assessment of their beef and beef offal is considered to be

5 of higher priority. - These opinions were summarised under the premise to implement a risk assessment, as a preliminary discussion before deciding whether or not to implement it. Appendix The rest is omitted.